|Publication number||US7377916 B2|
|Application number||US 10/753,693|
|Publication date||27 May 2008|
|Filing date||7 Jan 2004|
|Priority date||20 Jun 2003|
|Also published as||EP1635749A2, US7537592, US20040260276, US20040260322, WO2004112643A2, WO2004112643A3|
|Publication number||10753693, 753693, US 7377916 B2, US 7377916B2, US-B2-7377916, US7377916 B2, US7377916B2|
|Inventors||Robert I. Rudko, Mark R. Tauscher, Richard P. Yeomans, Jr.|
|Original Assignee||Plc Medical Systems, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (59), Non-Patent Citations (4), Referenced by (14), Classifications (11), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation-in-part application of U.S. patent application Ser. No. 10/600,175 filed on Jun. 20, 2003.
This invention relates to endovascular aortic valve replacement.
Currently, replacement of a malfunctioning heart valve is accomplished by a major open-heart surgical procedure requiring general anesthesia, full cardio-pulmonary bypass with complete cessation of cardio-pulmonary activity, and a long period of hospitalization and recuperation. In most cases, the native valve is resected (cut-out) and the replacement valve then installed.
As an alternative to open heart surgery, those skilled in the art have attempted to devise systems for endovascular heart valve replacement to overcome the disadvantages associated with open-heart surgery. U.S. Pat. No. 5,370,685, for example, discloses a procedure device capsule connected to a tube and delivered to the site via a guide wire introduced in the femoral artery of a patient. The device capsule houses an expandable barrier attached to balloon segments. Once the guide wire is removed and the barrier is expanded, a tissue cutting blade assembly is advanced in the tube and rotated by a DC motor to resect the existing valve. The barrier traps any debris cut by the tissue cutting blade assembly. Tissue is then suctioned out via the tube. Next, the cutting blade assembly is removed, the barrier balloons are deflated, and the barrier is brought back into the capsule and the capsule itself is removed.
Then, a valve introducer capsule is advanced to the site. The capsule houses a replacement valve and includes a pusher disk and inflatable balloon segments. After the balloon segments are inflated, the pusher disk pushes the replacement valve into position and a mounting balloon is used to expand the replacement valve and to secure it in place. Then, the introducer capsule is removed. The '685 patent is hereby incorporated herein. See also U.S. Pat. Nos. 5,545,214; 6,168,614; 5,840,081; 5,411,552; 5,370,685; and published Patent Application No. U.S. 2002/0058995 A1. These patents are also incorporated herein.
One problem with such a system is that the tissue cutting blade assembly is less than optimal and does not provide very precise cutting especially given the fact that the valve is made of both soft and hard tissue because it is heavily calcified or contains fibrotic tissue. Thus, the blades may buckle or bind as they alternately contact soft and hard tissue.
It is also presumed that pressure must be exerted on the blades. Control of this pressure and the control of the rotation rate, however, is not disclosed in the '685 patent. There is no margin for error in the resection procedure. If too much tissue is cut in certain areas, for example, the aorta can be permanently damaged. Moreover, the existing valve typically fails because of calcification of the valve resulting in stenosis or insufficiency. Using cutting blades for valve resection and an improper orientation or improper pressure on the cutting blades or the wrong rate of rotation can result in too little or too much tissue removal and/or imprecise cutting and/or blade buckling or binding as the blades alternately contact soft and hard (calcified) tissue.
Other relevant art includes the following, also included herein by this reference. Published Patent Application No. U.S. 2002/0095116 A1 discloses an aortic filter, an artery filter, and a check valve attached to the distal end of a canula for resecting an aortic valve from within the aorta. The mechanism for resecting the aortic valve, however, is not disclosed. U.S. Pat. No. 6,287,321 also discloses a percutaneous filtration catheter. U.S. Pat. No. 5,554,185 discloses an inflatable prosthetic cardiovascular valve but does not disclose any specific method of resecting the existing or native valve.
U.S. Pat. No. 6,425,916 discloses a percutaneous approach with a valve displacer for displacing and holding the native valve leaflets open while a replacement valve is expanded inside the native valve. In this way, the native valve does not need to be resected. In many cases, however, such a procedure can not be carried out due to the poor condition of the native valve. And, because the native valve occupies space, the largest aperture possible by the replacement valve may not provide sufficient blood flow.
U.S. Pat. Nos. 6,106,515 and 6,485,485, also incorporated herein by this reference, disclose various expandable laser catheter designs.
It is therefore an object of this invention to provide a more precise tissue cutting apparatus for endovascular heart valve replacement.
It is a further object of this invention to provide such a tissue cutter which is more effective than prior art blade type tissue cutters.
It is a further object of this invention to provide a tissue cutter which provides effective resection even if the valve is heavily calcified or has fibrotic tissue.
It is a further object of this invention to provide such a tissue cutter which does not require a high rate of rotation.
It is a further object of this invention to provide such a tissue cutter which eliminates the need for precise pressure control.
It is a further object of this invention to provide a mechanism which endovascularly supports the valve leaflets during resection.
The invention results from the realization that a more effective and more precise tissue cutting apparatus for endovascular heart valve replacement is effected by supporting the valve leaflets during resection using an expandable balloon advanced to the ventricular side of the valve. Various novel tissue ablation subassemblies are also disclosed as alterations to cutting blades.
This invention features an endovascular tissue removal system comprising an expandable mechanism introduceable to the ventricular side of a valve to support the leaflets of the valve in a closed position and a tissue removal device advanceable to the leaflets and configured to resect the leaflets as they are supported by the expandable mechanism.
In one embodiment, the tissue removal device includes a lumen connected to a source of ablation energy and further including an absorptive surface on the expandable mechanism for absorbing the ablation energy or a reflection surface for reflecting energy. The expandable mechanism is preferably a balloon.
In one example, the tissue removal device includes a lumen with a rotatable terminal hub advanceable in vasculature, at least one fiber extending from the hub for ablating tissue, and a second expandable mechanism connected to the fiber for biasing it into position for precisely ablating tissue as the hub rotates. There may be a plurality of fibers extending from the hub and connected to the second expandable mechanism so that the plurality of fibers can be spread apart for tissue ablation and also collapsed together for vascular insertion and removal. The second expandable mechanism is preferably a circumferentially expanding balloon. There may be two balloons, one inside and one outside of the distal end of the fiber. Typically, the lumen includes an inflation conduit therein connected to the balloon. The fiber may be an optical fiber connected to a source of laser energy or a waveguide connected to a source of laser energy.
Further included may be a tissue trap device surrounding the expandable mechanism. Typically, the fiber includes an angled distal portion. Also included may be a mirror for redirecting the ablation energy.
In another embodiment, the tissue removal device includes a lumen including a distal steerable tip portion extending from a joint portion, registration means for holding the joint portion fixed in place in the vasculature, and a source of ablation energy in communication with the lumen whereby tissue can be resected by ablation energy as the tip portion is steered within the vasculature. In one example, the registration means includes a second inflatable balloon about the joint portion, the source of ablation energy is a laser, the distal steerable tip portion includes a deflectable tip catheter, and there is an optical fiber inside the deflectable tip catheter and connected to the laser. An expandable barrier may be provided for trapping any debris resected.
Another tissue removal device includes a fiber advanceable within vasculature to ablate tissue, an outer expandable balloon, and an inner expandable balloon spaced from the outer expandable balloon forming a space within which the fiber travels to resect tissue. In one version, the outer expandable balloon is a portion of a tissue trap device and the distal end of the fiber is angled.
A method of endovascularly removing a heart valve in accordance with this invention comprises introducing an expandable mechanism to the ventricular side of the valve, expanding the mechanism to support the leaflets of the valve in a closed position, and resecting the leaflets of the valve as they are supported by the expandable mechanism.
Resecting typically includes directing ablative energy at the leaflets. A lumen is introduced within the vasculature of a patient to a situs proximate a heart valve to be resected, ablative energy is introduced into the lumen, and the lumen is rotated to resect the heart valve.
In another method, a lumen is endovascularly introduced with a distal steerable tip portion to a position proximate a valve to be resected, the lumen is registered in place in the vasculature, ablation energy is directed through the lumen, and the distal steerable tip portion is steered to resect the valve.
Other objects, features and advantages will occur to those skilled in the art from the following description of a preferred embodiment and the accompanying drawings, in which:
Aside from the preferred embodiment or embodiments disclosed below, this invention is capable of other embodiments and of being practiced or being carried out in various ways. Thus, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings.
But, the prior art teaches resection of the native valve tissue by tissue cutter 40,
As shown in
The problem is so profound that some skilled in the art have attempted to eliminate native valve resection and instead theorize that a prosthetic valve can be expanded directly within native valve 12 (or 14) using a valve displacer to hold the native valve open. As delineated above, however, due to the condition of the native valve, such a procedure is not always possible or effective.
In the subject invention, more precise tissue cutting is effected even if native valve 12,
Lower balloon 200 is disposable on the ventricular side of the heart valve under leaflets 204 and 206. Balloon 200 is connected to an inflation conduit which extends within multi-lumen catheter 100. An outer suction conduit may include a port for withdrawing tissue. Balloon 200 performs several important functions. First, it supports leaflets 204 and 206 of the valve as they are pushed closed by the tissue removal device before cutting for more accurate cutting. Balloon 200 with laser energy absorption or reflection layer 212 also prevents inadvertent cutting of any portion of mitral valve 216.
A complete system may include an expandable barrier such as barrier 30,
In this way, the problems associated with prior art blade type tissue cutters are eliminated and tissue cutting is far more precise by the use of optical fiber 110 within deflectable tip catheter 100 and expandable balloon 116 which registers the assembly inside the heart for resection by laser ablation as the deflectable tip portion steers the distal end of optical fiber 110.
In the embodiment of
In another embodiment, the endovascular tissue removal device 480,
In this way, the problem associated with prior art blade type tissue cutters are eliminated and tissue cutting is more precise by the use of electromagnetic energy in combination with the expandable balloon which spreads apart the plurality of optical fibers 488 and registration balloon 498 which registers the assembly inside the heart for resection typically as hub 484 rotates. The distal ends of optical fibers 488 are preferably precisely oriented to resect only valve tissue as shown by vectors 481 and 483,
A more complete system is shown in
In still another embodiment, optical fiber 488,
In the embodiment of
In the embodiment of
Although specific features of the invention are shown in some drawings and not in others, this is for convenience only as each feature may be combined with any or all of the other features in accordance with the invention. The words “including”, “comprising”, “having”, and “with” as used herein are to be interpreted broadly and comprehensively and are not limited to any physical interconnection. Moreover, any embodiments disclosed in the subject application are not to be taken as the only possible embodiments.
Other embodiments will occur to those skilled in the art and are within the following claims:
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|U.S. Classification||606/15, 606/7|
|International Classification||A61B18/24, A61B17/00, A61B17/22, A61B18/18|
|Cooperative Classification||A61B2017/22097, A61B2017/00243, A61B2017/22051, A61B18/24|
|7 Jan 2004||AS||Assignment|
Owner name: PLC MEDICAL SYSTEMS, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:RUDKO, ROBERT I.;YEOMANS, RICHARD P., JR.;TAUSCHER, MARKR.;REEL/FRAME:014883/0926
Effective date: 20031230
|9 Jan 2012||REMI||Maintenance fee reminder mailed|
|27 May 2012||LAPS||Lapse for failure to pay maintenance fees|